Medical devices and related methods and systems for data transfer

ABSTRACT

Medical devices and related systems and operating methods for communicating data therewith are provided. An exemplary method involves the medical device detecting an interfacing device coupled to the medical device via a physical communications medium, initializing a wireless communications session with the interfacing device in response to detecting the interfacing device, modulating an electrical signal between the interfacing device and the medical device to transmit data from the medical device to the interfacing device via the physical communications medium, and receiving communications, such as acknowledgments of the transmitted data, from the interfacing device via the wireless communications session.

TECHNICAL FIELD

Embodiments of the subject matter described herein relate generally tomedical devices, and more particularly, embodiments of the subjectmatter relate to communicating data with a fluid infusion device.

BACKGROUND

Infusion pump devices and systems are relatively well known in themedical arts, for use in delivering or dispensing an agent, such asinsulin or another prescribed medication, to a patient. Use of infusionpump therapy has been increasing, especially for delivering insulin fordiabetics. Some infusion pumps can be worn on the body of a patient andimplement control schemes that monitor and regulate a patient's bloodglucose level in a substantially continuous and autonomous manner.

Over time, the needs of a particular patient may change. For example, anindividual's insulin sensitivity and/or insulin requirements may changeas he or she ages or experiences lifestyle changes. Furthermore, eachindividual's needs may change in a manner that is unique relative toother patients. Accordingly, routine monitoring, doctor visits andmanual adjustments to device settings may be performed to accommodatechanges in an individual's needs. In such situations, it may bedesirable to transmit infusion pump data to another device formonitoring, analysis, processing, device diagnostics, or the like.However, it can be impractical, inconvenient, or unnecessary to transmitinfusion pump data on a frequent regular basis. Rather, larger batchesof data may be transmitted intermittently.

Wireless communications protocols may limit or restrict throughput andundesirably increase the duration of time required for transferring datafrom the infusion pump to a point where users could potentially becomefrustrated or discouraged from doing so as frequently as needed ordesired based on their medical condition. For example, Bluetooth lowenergy may limit bit rates to one megabit per second or less, which is afraction of what is achievable with modern wired communicationstechnologies. At the same time, providing an additional or dedicatedphysical communications interface can undesirably impact the size, formfactor, resiliency, cost, or other aspects of the infusion pump.Accordingly, it is desirable to facilitate communicating data from afluid infusion device in an expedient manner without compromising otherdesign aspects of the device.

BRIEF SUMMARY

Medical devices, systems, and related operating methods are provided. Anembodiment of a method of operating a medical device to communicate datais provided. The method involves the medical device detecting aninterfacing device coupled to the medical device, initializing awireless communications session with the interfacing device in responseto detecting the interfacing device, modulating an electrical signalbetween the interfacing device and the medical device to transmit datafrom the medical device to the interfacing device, and receivingcommunications from the interfacing device via the wirelesscommunications session.

A medical device communications system is also provided. The systemincludes an interfacing device and a medical device. The interfacingdevice includes a connection arrangement for a physical communicationsmedium and a first wireless communications module. The medical deviceincludes a data storage element to maintain operational data, a switchedresistance arrangement coupled to a terminal of the medical device, asecond wireless communications module, and a control module coupled tothe switched resistance arrangement and the second wirelesscommunications module. The control module initiates a wirelesscommunications session between the first and second wirelesscommunications modules in response to detecting the connectionarrangement being coupled to the terminal, operates the switchedresistance arrangement to modulate an electrical signal on the physicalcommunications medium in a manner corresponding to the operational data,and receives acknowledgment of the operational data from the interfacingdevice via the wireless communications session.

In another embodiment, a medical device is also provided. The medicaldevice includes a supply voltage terminal, a data storage element, aswitched resistance arrangement coupled to the supply voltage terminal,and a control module coupled to the switched resistance arrangement andthe wireless communications module. The control module transmitsoperational data maintained in the data storage element by operating theswitched resistance arrangement to modulate an input current at thesupply voltage terminal in a manner corresponding to the operationaldata and receives acknowledgment of the transmitted operational data viathe wireless communications module.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the detaileddescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the subject matter may be derived byreferring to the detailed description and claims when considered inconjunction with the following figures, wherein like reference numbersrefer to similar elements throughout the figures, which may beillustrated for simplicity and clarity and are not necessarily drawn toscale.

FIG. 1 depicts an exemplary embodiment of an infusion system;

FIG. 2 depicts a plan view of an exemplary embodiment of a fluidinfusion device suitable for use in the infusion system of FIG. 1;

FIG. 3 is an exploded perspective view of the fluid infusion device ofFIG. 2;

FIG. 4 is a cross-sectional view of the fluid infusion device of FIGS.2-3 as viewed along line 4-4 in FIG. 3 when assembled with a reservoirinserted in the infusion device;

FIG. 5 is a block diagram of an exemplary control system suitable foruse in a fluid infusion device, such as the fluid infusion device ofFIG. 1 or FIG. 2;

FIG. 6 is a block diagram of an exemplary medical device communicationssystem for transferring data between a medical device and an externalcomputing device using an interfacing device;

FIG. 7 is a schematic representation of the interfacing device and themedical device of FIG. 6 in one or more exemplary embodiments; and

FIG. 8 is a flow diagram of an exemplary data transfer process suitablefor use with the medical device communications system of FIG. 6 in oneor more exemplary embodiments.

DETAILED DESCRIPTION

The following detailed description is merely illustrative in nature andis not intended to limit the embodiments of the subject matter or theapplication and uses of such embodiments. As used herein, the word“exemplary” means “serving as an example, instance, or illustration.”Any implementation described herein as exemplary is not necessarily tobe construed as preferred or advantageous over other implementations.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description.

While the subject matter described herein can be implemented in anyelectronic device, exemplary embodiments described below are implementedin the form of medical devices, such as portable electronic medicaldevices. Although many different applications are possible, thefollowing description focuses on a fluid infusion device (or infusionpump) as part of an infusion system deployment. For the sake of brevity,conventional techniques related to infusion system operation, insulinpump and/or infusion set operation, and other functional aspects of thesystems (and the individual operating components of the systems) may notbe described in detail here. Examples of infusion pumps may be of thetype described in, but not limited to, U.S. Pat. Nos. 4,562,751;4,685,903; 5,080,653; 5,505,709; 5,097,122; 6,485,465; 6,554,798;6,558,320; 6,558,351; 6,641,533; 6,659,980; 6,752,787; 6,817,990;6,932,584; and 7,621,893; each of which are herein incorporated byreference.

Embodiments of the subject matter described herein generally relate tofluid infusion devices including a motor that is operable to linearlydisplace a plunger (or stopper) of a reservoir provided within the fluidinfusion device to deliver a dosage of fluid, such as insulin, to thebody of a user. Dosage commands that govern operation of the motor maybe generated in an automated manner in accordance with the deliverycontrol scheme associated with a particular operating mode, and thedosage commands may be generated in a manner that is influenced by acurrent (or most recent) measurement of a physiological condition in thebody of the user. For example, in a closed-loop operating mode, dosagecommands may be generated based on a difference between a current (ormost recent) measurement of the interstitial fluid glucose level in thebody of the user and a target (or reference) glucose value. In thisregard, the rate of infusion may vary as the difference between acurrent measurement value and the target measurement value fluctuates.For purposes of explanation, the subject matter is described herein inthe context of the infused fluid being insulin for regulating a glucoselevel of a user (or patient); however, it should be appreciated thatmany other fluids may be administered through infusion, and the subjectmatter described herein is not necessarily limited to use with insulin.

As described in greater detail below, primarily in the context of FIGS.6-8, in exemplary embodiments, the fluid infusion device automaticallydetects coupling of an interfacing device providing a physicalcommunications medium between the fluid infusion device and a computingdevice, and in response, initializes a wireless communications sessionwith the interfacing device. Thereafter, the fluid infusion devicetransmits operational data stored onboard the fluid infusion device tothe computing device via the interfacing device by modulating anelectrical signal between the interfacing device and the infusion devicein a manner corresponding to the data to be transmitted. For example, acontrol module of the fluid infusion device may alternately activate anddeactivate a switched resistance arrangement coupled to the physicalcommunications medium to modulate an input current to the fluid infusiondevice in a manner that corresponds to the bits of data beingtransmitted. The interfacing device receives or otherwise recognizes thetransmitted bits of data based on the electrical signal through thephysical communications medium and transmits or otherwise providesacknowledgments back to the infusion device via the wirelesscommunications session. In this manner, bandwidth of the physicalcommunications medium is not utilized for acknowledgments. Additionally,the interfacing device may request resending of any data that was notvalidly received.

In one exemplary embodiment, the interfacing device includes aconnection arrangement that conforms to an existing receptacle withinthe housing of the infusion device, such as a battery receptacle,thereby obviating the need for a dedicated interface on or within thehousing for the physical communications medium. In this regard, theconnection arrangement may electrically connect the physicalcommunications medium to the supply voltage terminal of the batteryconnector, with the switched resistance arrangement being coupledbetween the supply voltage terminal and a ground voltage terminal (ornode) of the infusion device to modulate the input current at the supplyvoltage terminal. A control module of the infusion device may detectinsertion of the connection arrangement in response to a voltage appliedat the supply voltage terminal increasing the voltage or power suppliedto the control module, and in response operate a wireless communicationsmodule of the infusion device to establish a wireless communicationssession with the interfacing device. The control module then locates orotherwise identifies the stored operational data to be transmitted in adata storage element (or memory), and then operates the switchedresistance arrangement accordingly. In this regard, the transmitted databits correspond to the stored data bits, but may also include errorcorrecting codes or other bits as dictated by the encoding and/orencryption schemes being utilized for a given deployment.

In exemplary embodiments, the interfacing device includes a currentsensing arrangement coupled to the physical communications medium thatgenerates an output influenced by the input current to the infusiondevice, and a control module of the interfacing device is coupled to theoutput of the current sensing arrangement to identify or otherwisereceive the bits of data being transmitted. In this regard, theinterfacing device control module may perform decoding, decryption,and/or error checking corresponding to the encoding, encryption and/orerror coding employed by the infusion device control module to verify orotherwise confirm that the transmitted data was validly received beforeeither transmitting an acknowledgment or a request to resend the datavia the wireless communications module.

The interfacing device control module transmits or otherwise providesthe received operational data to the computing device. Thereafter, thecomputing device may be utilized by a user to monitor or otherwiseanalyze the operational data, view graphical representations of theoperational data (e.g., delivery or dosage history, patient history,etc.), and the like, and based thereon, or modify infusion devicesettings, preferences, or other parameters. Any modified settings datamay then be uploaded to the infusion device by the computing devicetransmitting the data to the interfacing device control module, which,in turn, transmits the data to the infusion device via the wirelesscommunications session with the appropriate encoding, encryption, errorcoding, etc. The infusion device control module stores or otherwisemaintains any settings data received via the wireless communicationssession at the appropriate location(s) in the memory onboard theinfusion device, and thereafter, utilizes that settings data duringsubsequent operation of the infusion device.

Turning now to FIG. 1, one exemplary embodiment of an infusion system100 includes, without limitation, a fluid infusion device (or infusionpump) 102, a sensing arrangement 104, a command control device (CCD)106, and a computer 108. The components of an infusion system 100 may berealized using different platforms, designs, and configurations, and theembodiment shown in FIG. 1 is not exhaustive or limiting. In practice,the infusion device 102 and the sensing arrangement 104 are secured atdesired locations on the body of a user (or patient), as illustrated inFIG. 1. In this regard, the locations at which the infusion device 102and the sensing arrangement 104 are secured to the body of the user inFIG. 1 are provided only as a representative, non-limiting, example. Theelements of the infusion system 100 may be similar to those described inU.S. Pat. No. 8,674,288, the subject matter of which is herebyincorporated by reference in its entirety.

In the illustrated embodiment of FIG. 1, the infusion device 102 isdesigned as a portable medical device suitable for infusing a fluid, aliquid, a gel, or other agent into the body of a user. In exemplaryembodiments, the infused fluid is insulin, although many other fluidsmay be administered through infusion such as, but not limited to, HIVdrugs, drugs to treat pulmonary hypertension, iron chelation drugs, painmedications, anti-cancer treatments, medications, vitamins, hormones, orthe like. In some embodiments, the fluid may include a nutritionalsupplement, a dye, a tracing medium, a saline medium, a hydrationmedium, or the like.

The sensing arrangement 104 generally represents the components of theinfusion system 100 configured to sense, detect, measure or otherwisequantify a condition of the user, and may include a sensor, a monitor,or the like, for providing data indicative of the condition that issensed, detected, measured or otherwise monitored by the sensingarrangement. In this regard, the sensing arrangement 104 may includeelectronics and enzymes reactive to a biological condition, such as ablood glucose level, or the like, of the user, and provide dataindicative of the blood glucose level to the infusion device 102, theCCD 106 and/or the computer 108. For example, the infusion device 102,the CCD 106 and/or the computer 108 may include a display for presentinginformation or data to the user based on the sensor data received fromthe sensing arrangement 104, such as, for example, a current glucoselevel of the user, a graph or chart of the user's glucose level versustime, device status indicators, alert messages, or the like. In otherembodiments, the infusion device 102, the CCD 106 and/or the computer108 may include electronics and software that are configured to analyzesensor data and operate the infusion device 102 to deliver fluid to thebody of the user based on the sensor data and/or preprogrammed deliveryroutines. Thus, in exemplary embodiments, one or more of the infusiondevice 102, the sensing arrangement 104, the CCD 106, and/or thecomputer 108 includes a transmitter, a receiver, and/or othertransceiver electronics that allow for communication with othercomponents of the infusion system 100, so that the sensing arrangement104 may transmit sensor data or monitor data to one or more of theinfusion device 102, the CCD 106 and/or the computer 108.

Still referring to FIG. 1, in various embodiments, the sensingarrangement 104 may be secured to the body of the user or embedded inthe body of the user at a location that is remote from the location atwhich the infusion device 102 is secured to the body of the user. Invarious other embodiments, the sensing arrangement 104 may beincorporated within the infusion device 102. In other embodiments, thesensing arrangement 104 may be separate and apart from the infusiondevice 102, and may be, for example, part of the CCD 106. In suchembodiments, the sensing arrangement 104 may be configured to receive abiological sample, analyte, or the like, to measure a condition of theuser.

As described above, in some embodiments, the CCD 106 and/or the computer108 may include electronics and other components configured to performprocessing, delivery routine storage, and to control the infusion device102 in a manner that is influenced by sensor data measured by and/orreceived from the sensing arrangement 104. By including controlfunctions in the CCD 106 and/or the computer 108, the infusion device102 may be made with more simplified electronics. However, in otherembodiments, the infusion device 102 may include all control functions,and may operate without the CCD 106 and/or the computer 108. In variousembodiments, the CCD 106 may be a portable electronic device. Inaddition, in various embodiments, the infusion device 102 and/or thesensing arrangement 104 may be configured to transmit data to the CCD106 and/or the computer 108 for display or processing of the data by theCCD 106 and/or the computer 108.

In some embodiments, the CCD 106 and/or the computer 108 may provideinformation to the user that facilitates the user's subsequent use ofthe infusion device 102. For example, the CCD 106 may provideinformation to the user to allow the user to determine the rate or doseof medication to be administered into the user's body. In otherembodiments, the CCD 106 may provide information to the infusion device102 to autonomously control the rate or dose of medication administeredinto the body of the user. In some embodiments, the sensing arrangement104 may be integrated into the CCD 106. Such embodiments may allow theuser to monitor a condition by providing, for example, a sample of hisor her blood to the sensing arrangement 104 to assess his or hercondition. In some embodiments, the sensing arrangement 104 and the CCD106 may be used for determining glucose levels in the blood and/or bodyfluids of the user without the use of, or necessity of, a wire or cableconnection between the infusion device 102 and the sensing arrangement104 and/or the CCD 106.

In some embodiments, the sensing arrangement 104 and/or the infusiondevice 102 are cooperatively configured to utilize a closed-loop systemfor delivering fluid to the user. Examples of sensing devices and/orinfusion pumps utilizing closed-loop systems may be found at, but arenot limited to, the following U.S. Pat. Nos. 6,088,608, 6,119,028,6,589,229, 6,740,072, 6,827,702, 7,323,142, and 7,402, 153, all of whichare incorporated herein by reference in their entirety. In suchembodiments, the sensing arrangement 104 is configured to sense ormeasure a condition of the user, such as, blood glucose level or thelike. The infusion device 102 is configured to deliver fluid in responseto the condition sensed by the sensing arrangement 104. In turn, thesensing arrangement 104 continues to sense or otherwise quantify acurrent condition of the user, thereby allowing the infusion device 102to deliver fluid continuously in response to the condition currently (ormost recently) sensed by the sensing arrangement 104 indefinitely. Insome embodiments, the sensing arrangement 104 and/or the infusion device102 may be configured to utilize the closed-loop system only for aportion of the day, for example only when the user is asleep or awake.

FIGS. 2-4 depict one exemplary embodiment of a fluid infusion device 200(or alternatively, infusion pump) suitable for use in an infusionsystem, such as, for example, as infusion device 102 in the infusionsystem 100 of FIG. 1. The fluid infusion device 200 is a portablemedical device designed to be carried or worn by a patient (or user),and the fluid infusion device 200 may leverage any number ofconventional features, components, elements, and characteristics ofexisting fluid infusion devices, such as, for example, some of thefeatures, components, elements, and/or characteristics described in U.S.Pat. Nos. 6,485,465 and 7,621,893. It should be appreciated that FIGS.2-4 depict some aspects of the infusion device 200 in a simplifiedmanner; in practice, the infusion device 200 could include additionalelements, features, or components that are not shown or described indetail herein.

As best illustrated in FIGS. 2-3, the illustrated embodiment of thefluid infusion device 200 includes a housing 202 adapted to receive afluid-containing reservoir 205. An opening 220 in the housing 202accommodates a fitting 223 (or cap) for the reservoir 205, with thefitting 223 being configured to mate or otherwise interface with tubing221 of an infusion set 225 that provides a fluid path to/from the bodyof the user. In this manner, fluid communication from the interior ofthe reservoir 205 to the user is established via the tubing 221. Theillustrated fluid infusion device 200 includes a human-machine interface(HMI) 230 (or user interface) that includes elements 232, 234 that canbe manipulated by the user to administer a bolus of fluid (e.g.,insulin), to change therapy settings, to change user preferences, toselect display features, and the like. The infusion device also includesa display element 226, such as a liquid crystal display (LCD) or anothersuitable display element, that can be used to present various types ofinformation or data to the user, such as, without limitation: thecurrent glucose level of the patient; the time; a graph or chart of thepatient's glucose level versus time; device status indicators; etc.

The housing 202 is formed from a substantially rigid material having ahollow interior 214 adapted to allow an electronics assembly 204, asliding member (or slide) 206, a drive system 208, a sensor assembly210, and a drive system capping member 212 to be disposed therein inaddition to the reservoir 205, with the contents of the housing 202being enclosed by a housing capping member 216. The opening 220, theslide 206, and the drive system 208 are coaxially aligned in an axialdirection (indicated by arrow 218), whereby the drive system 208facilitates linear displacement of the slide 206 in the axial direction218 to dispense fluid from the reservoir 205 (after the reservoir 205has been inserted into opening 220), with the sensor assembly 210 beingconfigured to measure axial forces (e.g., forces aligned with the axialdirection 218) exerted on the sensor assembly 210 responsive tooperating the drive system 208 to displace the slide 206. In variousembodiments, the sensor assembly 210 may be utilized to detect one ormore of the following: an occlusion in a fluid path that slows,prevents, or otherwise degrades fluid delivery from the reservoir 205 toa user's body; when the reservoir 205 is empty; when the slide 206 isproperly seated with the reservoir 205; when a fluid dose has beendelivered; when the infusion pump 200 is subjected to shock orvibration; when the infusion pump 200 requires maintenance.

Depending on the embodiment, the fluid-containing reservoir 205 may berealized as a syringe, a vial, a cartridge, a bag, or the like. Incertain embodiments, the infused fluid is insulin, although many otherfluids may be administered through infusion such as, but not limited to,HIV drugs, drugs to treat pulmonary hypertension, iron chelation drugs,pain medications, anti-cancer treatments, medications, vitamins,hormones, or the like. As best illustrated in FIGS. 3-4, the reservoir205 typically includes a reservoir barrel 219 that contains the fluidand is concentrically and/or coaxially aligned with the slide 206 (e.g.,in the axial direction 218) when the reservoir 205 is inserted into theinfusion pump 200. The end of the reservoir 205 proximate the opening220 may include or otherwise mate with the fitting 223, which securesthe reservoir 205 in the housing 202 and prevents displacement of thereservoir 205 in the axial direction 218 with respect to the housing 202after the reservoir 205 is inserted into the housing 202. As describedabove, the fitting 223 extends from (or through) the opening 220 of thehousing 202 and mates with tubing 221 to establish fluid communicationfrom the interior of the reservoir 205 (e.g., reservoir barrel 219) tothe user via the tubing 221 and infusion set 225. The opposing end ofthe reservoir 205 proximate the slide 206 includes a plunger 217 (orstopper) positioned to push fluid from inside the barrel 219 of thereservoir 205 along a fluid path through tubing 221 to a user. The slide206 is configured to mechanically couple or otherwise engage with theplunger 217, thereby becoming seated with the plunger 217 and/orreservoir 205. Fluid is forced from the reservoir 205 via tubing 221 asthe drive system 208 is operated to displace the slide 206 in the axialdirection 218 toward the opening 220 in the housing 202.

In the illustrated embodiment of FIGS. 3-4, the drive system 208includes a motor assembly 207 and a drive screw 209. The motor assembly207 includes a motor that is coupled to drive train components of thedrive system 208 that are configured to convert rotational motor motionto a translational displacement of the slide 206 in the axial direction218, and thereby engaging and displacing the plunger 217 of thereservoir 205 in the axial direction 218. In some embodiments, the motorassembly 207 may also be powered to translate the slide 206 in theopposing direction (e.g., the direction opposite direction 218) toretract and/or detach from the reservoir 205 to allow the reservoir 205to be replaced. In exemplary embodiments, the motor assembly 207includes a brushless DC (BLDC) motor having one or more permanentmagnets mounted, affixed, or otherwise disposed on its rotor. However,the subject matter described herein is not necessarily limited to usewith BLDC motors, and in alternative embodiments, the motor may berealized as a solenoid motor, an AC motor, a stepper motor, apiezoelectric caterpillar drive, a shape memory actuator drive, anelectrochemical gas cell, a thermally driven gas cell, a bimetallicactuator, or the like. The drive train components may comprise one ormore lead screws, cams, ratchets, jacks, pulleys, pawls, clamps, gears,nuts, slides, bearings, levers, beams, stoppers, plungers, sliders,brackets, guides, bearings, supports, bellows, caps, diaphragms, bags,heaters, or the like. In this regard, although the illustratedembodiment of the infusion pump utilizes a coaxially aligned drivetrain, the motor could be arranged in an offset or otherwise non-coaxialmanner, relative to the longitudinal axis of the reservoir 205.

As best shown in FIG. 4, the drive screw 209 mates with threads 402internal to the slide 206. When the motor assembly 207 is powered andoperated, the drive screw 209 rotates, and the slide 206 is forced totranslate in the axial direction 218. In an exemplary embodiment, theinfusion pump 200 includes a sleeve 211 to prevent the slide 206 fromrotating when the drive screw 209 of the drive system 208 rotates. Thus,rotation of the drive screw 209 causes the slide 206 to extend orretract relative to the drive motor assembly 207. When the fluidinfusion device is assembled and operational, the slide 206 contacts theplunger 217 to engage the reservoir 205 and control delivery of fluidfrom the infusion pump 200. In an exemplary embodiment, the shoulderportion 215 of the slide 206 contacts or otherwise engages the plunger217 to displace the plunger 217 in the axial direction 218. Inalternative embodiments, the slide 206 may include a threaded tip 213capable of being detachably engaged with internal threads 404 on theplunger 217 of the reservoir 205, as described in detail in U.S. Pat.Nos. 6,248,093 and 6,485,465, which are incorporated by referenceherein.

As illustrated in FIG. 3, the electronics assembly 204 includes controlelectronics 224 coupled to the display element 226, with the housing 202including a transparent window portion 228 that is aligned with thedisplay element 226 to allow the display 226 to be viewed by the userwhen the electronics assembly 204 is disposed within the interior 214 ofthe housing 202. The control electronics 224 generally represent thehardware, firmware, processing logic and/or software (or combinationsthereof) configured to control operation of the motor assembly 207and/or drive system 208, as described in greater detail below in thecontext of FIG. 5. Whether such functionality is implemented ashardware, firmware, a state machine, or software depends upon theparticular application and design constraints imposed on the embodiment.Those familiar with the concepts described here may implement suchfunctionality in a suitable manner for each particular application, butsuch implementation decisions should not be interpreted as beingrestrictive or limiting. In an exemplary embodiment, the controlelectronics 224 includes one or more programmable controllers that maybe programmed to control operation of the infusion pump 200.

The motor assembly 207 includes one or more electrical leads 236 adaptedto be electrically coupled to the electronics assembly 204 to establishcommunication between the control electronics 224 and the motor assembly207. In response to command signals from the control electronics 224that operate a motor driver (e.g., a power converter) to regulate theamount of power supplied to the motor from a power supply, the motoractuates the drive train components of the drive system 208 to displacethe slide 206 in the axial direction 218 to force fluid from thereservoir 205 along a fluid path (including tubing 221 and an infusionset), thereby administering doses of the fluid contained in thereservoir 205 into the user's body. Preferably, the power supply isrealized one or more batteries contained within the housing 202.Alternatively, the power supply may be a solar panel, capacitor, AC orDC power supplied through a power cord, or the like. In someembodiments, the control electronics 224 may operate the motor of themotor assembly 207 and/or drive system 208 in a stepwise manner,typically on an intermittent basis; to administer discrete precise dosesof the fluid to the user according to programmed delivery profiles.

Referring to FIGS. 2-4, as described above, the user interface 230includes HMI elements, such as buttons 232 and a directional pad 234,that are formed on a graphic keypad overlay 231 that overlies a keypadassembly 233, which includes features corresponding to the buttons 232,directional pad 234 or other user interface items indicated by thegraphic keypad overlay 231. When assembled, the keypad assembly 233 iscoupled to the control electronics 224, thereby allowing the HMIelements 232, 234 to be manipulated by the user to interact with thecontrol electronics 224 and control operation of the infusion pump 200,for example, to administer a bolus of insulin, to change therapysettings, to change user preferences, to select display features, to setor disable alarms and reminders, and the like. In this regard, thecontrol electronics 224 maintains and/or provides information to thedisplay 226 regarding program parameters, delivery profiles, pumpoperation, alarms, warnings, statuses, or the like, which may beadjusted using the HMI elements 232, 234. In various embodiments, theHMI elements 232, 234 may be realized as physical objects (e.g.,buttons, knobs, joysticks, and the like) or virtual objects (e.g., usingtouch-sensing and/or proximity-sensing technologies). For example, insome embodiments, the display 226 may be realized as a touch screen ortouch-sensitive display, and in such embodiments, the features and/orfunctionality of the HMI elements 232, 234 may be integrated into thedisplay 226 and the HMI 230 may not be present. In some embodiments, theelectronics assembly 204 may also include alert generating elementscoupled to the control electronics 224 and suitably configured togenerate one or more types of feedback, such as, without limitation:audible feedback; visual feedback; haptic (physical) feedback; or thelike.

Referring to FIGS. 3-4, in accordance with one or more embodiments, thesensor assembly 210 includes a back plate structure 250 and a loadingelement 260. The loading element 260 is disposed between the cappingmember 212 and a beam structure 270 that includes one or more beamshaving sensing elements disposed thereon that are influenced bycompressive force applied to the sensor assembly 210 that deflects theone or more beams, as described in greater detail in U.S. Pat. No.8,474,332, which is incorporated by reference herein. In exemplaryembodiments, the back plate structure 250 is affixed, adhered, mounted,or otherwise mechanically coupled to the bottom surface 238 of the drivesystem 208 such that the back plate structure 250 resides between thebottom surface 238 of the drive system 208 and the housing cap 216. Thedrive system capping member 212 is contoured to accommodate and conformto the bottom of the sensor assembly 210 and the drive system 208. Thedrive system capping member 212 may be affixed to the interior of thehousing 202 to prevent displacement of the sensor assembly 210 in thedirection opposite the direction of force provided by the drive system208 (e.g., the direction opposite direction 218). Thus, the sensorassembly 210 is positioned between the motor assembly 207 and secured bythe capping member 212, which prevents displacement of the sensorassembly 210 in a downward direction opposite the direction of arrow218, such that the sensor assembly 210 is subjected to a reactionarycompressive force when the drive system 208 and/or motor assembly 207 isoperated to displace the slide 206 in the axial direction 218 inopposition to the fluid pressure in the reservoir 205. Under normaloperating conditions, the compressive force applied to the sensorassembly 210 is correlated with the fluid pressure in the reservoir 205.As shown, electrical leads 240 are adapted to electrically couple thesensing elements of the sensor assembly 210 to the electronics assembly204 to establish communication to the control electronics 224, whereinthe control electronics 224 are configured to measure, receive, orotherwise obtain electrical signals from the sensing elements of thesensor assembly 210 that are indicative of the force applied by thedrive system 208 in the axial direction 218.

As illustrated in FIG. 3, the hollow interior 214 defined by the housingalso includes with a portion configured to receive or otherwise conformto a battery (i.e., a battery receptacle), which mates with a connector280 configured to establish an electrical connection from the battery tothe drive system 208, the control electronics 224, the display 226and/or other components of the infusion device 200. A battery cap 282retains the battery within the housing 202 and engaged with theconnector 280 when assembled. As described in greater detail below inthe context of FIGS. 6-8, in one or more exemplary embodiments, in lieuof a dedicated physical communications interface, the battery cap 282and any battery may be removed from the infusion device 200 and replacedwith a battery emulator having substantially the same shape as thebattery and an integrated cap configured to provide a physicalcommunications interface to the control electronics 224 and/or othercomponents of the infusion device 200. For example, the hollow interior214 and battery connector 280 may be configured to receive and conformto a AA-sized battery, whereby the battery emulator has substantiallythe same size and form factor as a AA-sized battery to support insertioninto the housing 202 and engagement with the battery connector 280 in asubstantially similar manner as the battery. The battery cap associatedwith the battery emulator then retains the battery emulator engaged withthe battery connector 280 while also supporting a physical interface forelectrical communications to/from the control electronics 224 and/orother components of the infusion device 200 via the battery emulator andthe connector 280.

FIG. 5 depicts an exemplary embodiment of a control system 500 suitablefor use with an infusion device 502, such as the infusion device 102 inFIG. 1 or the infusion device 200 of FIG. 2. The control system 500 iscapable of controlling or otherwise regulating a physiological conditionin the body 501 of a user to a desired (or target) value or otherwisemaintain the condition within a range of acceptable values in anautomated manner. In one or more exemplary embodiments, the conditionbeing regulated is sensed, detected, measured or otherwise quantified bya sensing arrangement 504 (e.g., sensing arrangement 104)communicatively coupled to the infusion device 502. However, it shouldbe noted that in alternative embodiments, the condition being regulatedby the control system 500 may be correlative to the measured valuesobtained by the sensing arrangement 504. That said, for clarity andpurposes of explanation, the subject matter may be described herein inthe context of the sensing arrangement 504 being realized as a glucosesensing arrangement that senses, detects, measures or otherwisequantifies the user's glucose level, which is being regulated in thebody 501 of the user by the control system 500.

In exemplary embodiments, the sensing arrangement 504 includes one ormore interstitial glucose sensing elements that generate or otherwiseoutput electrical signals having a signal characteristic that iscorrelative to, influenced by, or otherwise indicative of the relativeinterstitial fluid glucose level in the body 501 of the user. The outputelectrical signals are filtered or otherwise processed to obtain ameasurement value indicative of the user's interstitial fluid glucoselevel. In exemplary embodiments, a blood glucose meter 530, such as afinger stick device, is utilized to directly sense, detect, measure orotherwise quantify the blood glucose in the body 501 of the user. Inthis regard, the blood glucose meter 530 outputs or otherwise provides ameasured blood glucose value that may be utilized as a referencemeasurement for calibrating the sensing arrangement 504 and converting ameasurement value indicative of the user's interstitial fluid glucoselevel into a corresponding calibrated blood glucose value. For purposesof explanation, the calibrated blood glucose value calculated based onthe electrical signals output by the sensing element(s) of the sensingarrangement 504 may alternatively be referred to herein as the sensorglucose value, the sensed glucose value, or variants thereof.

In the illustrated embodiment, the pump control system 520 generallyrepresents the electronics and other components of the infusion device502 that control operation of the fluid infusion device 502 according toa desired infusion delivery program in a manner that is influenced bythe sensed glucose value indicative of a current glucose level in thebody 501 of the user. For example, to support a closed-loop operatingmode, the pump control system 520 maintains, receives, or otherwiseobtains a target or commanded glucose value, and automatically generatesor otherwise determines dosage commands for operating the motor 507 todisplace the plunger 517 and deliver insulin to the body 501 of the userbased on the difference between a sensed glucose value and the targetglucose value. In other operating modes, the pump control system 520 maygenerate or otherwise determine dosage commands configured to maintainthe sensed glucose value below an upper glucose limit, above a lowerglucose limit, or otherwise within a desired range of glucose values. Inpractice, the infusion device 502 may store or otherwise maintain thetarget value, upper and/or lower glucose limit(s), and/or other glucosethreshold value(s) in a data storage element accessible to the pumpcontrol system 520.

The target glucose value and other threshold glucose values may bereceived from an external component (e.g., CCD 106 and/or computingdevice 108) or be input by a user via a user interface element 540associated with the infusion device 502. In practice, the one or moreuser interface element(s) 540 associated with the infusion device 502typically include at least one input user interface element, such as,for example, a button, a keypad, a keyboard, a knob, a joystick, amouse, a touch panel, a touchscreen, a microphone or another audio inputdevice, and/or the like. Additionally, the one or more user interfaceelement(s) 540 include at least one output user interface element, suchas, for example, a display element (e.g., a light-emitting diode or thelike), a display device (e.g., a liquid crystal display or the like), aspeaker or another audio output device, a haptic feedback device, or thelike, for providing notifications or other information to the user. Itshould be noted that although FIG. 5 depicts the user interfaceelement(s) 540 as being separate from the infusion device 502, inpractice, one or more of the user interface element(s) 540 may beintegrated with the infusion device 502. Furthermore, in someembodiments, one or more user interface element(s) 540 are integratedwith the sensing arrangement 504 in addition to and/or in alternative tothe user interface element(s) 540 integrated with the infusion device502. The user interface element(s) 540 may be manipulated by the user tooperate the infusion device 502 to deliver correction boluses, adjusttarget and/or threshold values, modify the delivery control scheme oroperating mode, and the like, as desired.

Still referring to FIG. 5, in the illustrated embodiment, the infusiondevice 502 includes a motor control module 512 coupled to a motor 507(e.g., motor assembly 207) that is operable to displace a plunger 517(e.g., plunger 217) in a reservoir (e.g., reservoir 205) and provide adesired amount of fluid to the body 501 of a user. In this regard,displacement of the plunger 517 results in the delivery of a fluid thatis capable of influencing the condition in the body 501 of the user tothe body 501 of the user via a fluid delivery path (e.g., via tubing 221of an infusion set 225). A motor driver module 514 is coupled between anenergy source 503 and the motor 507. The motor control module 512 iscoupled to the motor driver module 514, and the motor control module 512generates or otherwise provides command signals that operate the motordriver module 514 to provide current (or power) from the energy source503 to the motor 507 to displace the plunger 517 in response toreceiving, from a pump control system 520, a dosage command indicativeof the desired amount of fluid to be delivered.

In exemplary embodiments, the energy source 503 is realized as a batteryhoused within the infusion device 502 (e.g., within housing 202) thatprovides direct current (DC) power. In this regard, the motor drivermodule 514 generally represents the combination of circuitry, hardwareand/or other electrical components configured to convert or otherwisetransfer DC power provided by the energy source 503 into alternatingelectrical signals applied to respective phases of the stator windingsof the motor 507 that result in current flowing through the statorwindings that generates a stator magnetic field and causes the rotor ofthe motor 507 to rotate. The motor control module 512 is configured toreceive or otherwise obtain a commanded dosage from the pump controlsystem 520, convert the commanded dosage to a commanded translationaldisplacement of the plunger 517, and command, signal, or otherwiseoperate the motor driver module 514 to cause the rotor of the motor 507to rotate by an amount that produces the commanded translationaldisplacement of the plunger 517. For example, the motor control module512 may determine an amount of rotation of the rotor required to producetranslational displacement of the plunger 517 that achieves thecommanded dosage received from the pump control system 520. Based on thecurrent rotational position (or orientation) of the rotor with respectto the stator that is indicated by the output of the rotor sensingarrangement 516, the motor control module 512 determines the appropriatesequence of alternating electrical signals to be applied to therespective phases of the stator windings that should rotate the rotor bythe determined amount of rotation from its current position (ororientation). In embodiments where the motor 507 is realized as a BLDCmotor, the alternating electrical signals commutate the respectivephases of the stator windings at the appropriate orientation of therotor magnetic poles with respect to the stator and in the appropriateorder to provide a rotating stator magnetic field that rotates the rotorin the desired direction. Thereafter, the motor control module 512operates the motor driver module 514 to apply the determined alternatingelectrical signals (e.g., the command signals) to the stator windings ofthe motor 507 to achieve the desired delivery of fluid to the user.

When the motor control module 512 is operating the motor driver module514, current flows from the energy source 503 through the statorwindings of the motor 507 to produce a stator magnetic field thatinteracts with the rotor magnetic field. In some embodiments, after themotor control module 512 operates the motor driver module 514 and/ormotor 507 to achieve the commanded dosage, the motor control module 512ceases operating the motor driver module 514 and/or motor 507 until asubsequent dosage command is received. In this regard, the motor drivermodule 514 and the motor 507 enter an idle state during which the motordriver module 514 effectively disconnects or isolates the statorwindings of the motor 507 from the energy source 503. In other words,current does not flow from the energy source 503 through the statorwindings of the motor 507 when the motor 507 is idle, and thus, themotor 507 does not consume power from the energy source 503 in the idlestate, thereby improving efficiency.

Depending on the embodiment, the motor control module 512 may beimplemented or realized with a general purpose processor, amicroprocessor, a controller, a microcontroller, a state machine, acontent addressable memory, an application specific integrated circuit,a field programmable gate array, any suitable programmable logic device,discrete gate or transistor logic, discrete hardware components, or anycombination thereof, designed to perform the functions described herein.In exemplary embodiments, the motor control module 512 includes orotherwise accesses a data storage element or memory, including any sortof random access memory (RAM), read only memory (ROM), flash memory,registers, hard disks, removable disks, magnetic or optical massstorage, or any other short or long term storage media or othernon-transitory computer-readable medium, which is capable of storingprogramming instructions for execution by the motor control module 512.The computer-executable programming instructions, when read and executedby the motor control module 512, cause the motor control module 512 toperform or otherwise support the tasks, operations, functions, andprocesses described herein.

It should be appreciated that FIG. 5 is a simplified representation ofthe infusion device 502 for purposes of explanation and is not intendedto limit the subject matter described herein in any way. In this regard,depending on the embodiment, some features and/or functionality of thesensing arrangement 504 may implemented by or otherwise integrated intothe pump control system 520, or vice versa. Similarly, in practice, thefeatures and/or functionality of the motor control module 512 mayimplemented by or otherwise integrated into the pump control system 520,or vice versa. Furthermore, the features and/or functionality of thepump control system 520 may be implemented by control electronics 224located in the fluid infusion device 200, 400, while in alternativeembodiments, the pump control system 520 may be implemented by a remotecomputing device that is physically distinct and/or separate from theinfusion device 502, such as, for example, the CCD 106 or the computingdevice 108.

FIG. 6 depicts an exemplary embodiment of a system 600 for transferringdata between an infusion device 602 and a computing device 604. Aninterfacing device 606 provides a physical communications medium 607between the infusion device 602 and the computing device 604 while alsosupporting wireless communications with the infusion device 602, asdescribed in greater detail below. In exemplary embodiments, theinterfacing device 606 supports unidirectional communications from theinfusion device 602 to the computing device 604 via the physicalcommunications medium 607 while supporting bidirectional wirelesscommunications with the infusion device 602.

The interfacing device 606 includes a first connection arrangement 608that is coupled to the computing device 604 to provide an electricalinterconnection between the computing device and the physicalcommunications medium 607. For example, the physical communicationsmedium 607 may be realized as a cable compatible with a universal serialbus (USB) standard, where the connection arrangement 608 is realized asa USB connector capable of mating with or otherwise inserted in acorresponding receptacle on the computing device 604. That said, itshould be noted that the subject matter is not limited to a particulartype of physical communications medium or connection arrangement for thecomputing device 604.

The interfacing device 606 also includes another connection arrangement610 that is coupled to the infusion device 602 to provide an electricalinterconnection between the infusion device 602 and the physicalcommunications medium 607. In exemplary embodiments, the infusion deviceconnection arrangement 610 is realized as a battery emulator integratedwith a capping member 630 that can be screwed (e.g., using threadsformed on or in the capping member 630) or otherwise fastened with thehousing of the infusion device 602. In this regard, the battery emulatormay have a form factor corresponding to the battery normally utilized inthe infusion device 602 so that the battery emulator supports anelectrical connection to the internal circuitry of the infusion device602 via the terminals of the battery connector (e.g., battery connector280) within the infusion device housing. The capping member 630integrated with the battery emulator may similarly emulate the batterycap (e.g., battery cap 282) and hold the battery emulator engaged withthe battery connector when screwed on to the infusion device 602.Additionally, the capping member 630 provides an electricalinterconnection between the battery emulator and the physicalcommunications medium 607. Thus, the infusion device connectionarrangement 610 provides an electrical connection between the physicalcommunications medium 607 and the internal electrical components of theinfusion device 602 via the capping member 630 and the battery emulatorengaged with the terminals of the internal battery connector.

In exemplary embodiments, the interfacing device 606 also includescircuitry 620 that manages or otherwise controls communications betweenthe infusion device 602 and the computing device 604 via the interfacingdevice 606. The management circuitry 620 is arranged between theinfusion device 602 and the computing device 604, and depending on theembodiment, portions of the management circuitry 620 may be integratedwith the physical communications medium 607, the external deviceconnection arrangement 608, and/or the infusion device connectionarrangement 610. Thus, while FIG. 6 depicts the management circuitry 620as being integrated with the physical communications medium 607, invarious alternative embodiments, components of the management circuitry620 may be distributed throughout the interfacing device 606 to achievea desired form factor for the interfacing device 606.

FIG. 7 depicts a schematic view of an exemplary embodiment of themanagement circuitry 620 interfacing with internal circuitry of theinfusion device 602 via the infusion device connection arrangement 610.The illustrated embodiment depicts the external device connectionarrangement 608 being realized as a USB connector including fourinput/output (I/O) terminals: a positive (or supply) reference voltageterminal 702, a negative (or ground) reference voltage terminal 704, anddifferential data signal terminals 706, 708. The management circuitry620 includes a voltage converter 712, such as a DC-to-DC buck converter,that is coupled to the reference voltages at terminals 702, 704 andconverts the voltage differential between those terminals 702, 704 tothe infusion device supply voltage corresponding to battery typicallyutilized in the infusion device 602. For example, in the case of a 1.5Volt AA battery being utilized in the infusion device 602 and theconnection arrangement 608 being realized as a USB connector providing a5 Volt bus voltage, the DC-to-DC buck converter 712 converts the 5 Voltsfrom the computing device 604 to 1.5 Volts that are output or otherwiseprovided to the infusion device connection arrangement 610 via theportion of the physical communications medium 607 between the voltageconverter 712 and the infusion device connection arrangement 610. Thatsaid, it should be noted that in various embodiments, the output voltageof the voltage converter 712 may be different from the nominal batterysupply voltage for the infusion device 602, and in some cases, may bevariable or adjustable (e.g., under the control of the communicationscontrol module 710) to facilitate automated detection of the interfacingdevice 606, communications to/from the infusion device 602, or the like.The illustrated circuitry 620 also includes a linear regulator 722having inputs coupled to the reference voltages at terminals 702, 704that converts the voltage differential between those terminals 702, 704to a supply reference voltage for other components 710, 716, 718, 720 ofthe circuitry 620 (e.g., from 5 Volts to 3.3 Volts).

As illustrated, a resistive element 714 is electrically connected inseries between the output of the voltage converter 712 (VOUT) and theinfusion device connection arrangement 610 so that any current drawnfrom the interfacing device 606 by the infusion device 602 flows throughthe resistive element 714. A current sensing arrangement 716 includesinputs electrically connected to both ends of the resistive element 714to detect or otherwise identify a voltage drop across the resistiveelement 714, which, in turn, is indicative of a current through theresistive element 714. The current sensing arrangement 716 compares thedetected voltage to a threshold, and generates a logical high voltageoutput (e.g., logic ‘1’ or 3.3 Volts) when the detected voltage isgreater than the threshold, and otherwise generates a logical lowvoltage (e.g., logic ‘0’ or 0 Volts) when the detected voltage is lessthan the threshold. In this manner, the current sensing arrangement 716and the resistive element 714 are cooperatively configured to detectwhen current flows from the interfacing device 606 to the infusiondevice 602, where the output from the current sensing arrangement 716corresponds to a bit of serial data transmitted by the infusion device602, as described in greater detail below.

In exemplary embodiments, the current sensing arrangement 716 alsoincludes, incorporates, or otherwise supports automatic gain control andoffset compensation configured such that the nominal current consumptionof the infusion device 602 during normal operation (and also any currentconsumption that is less than that amount) represents a logical lowvoltage output, while a current through the resistive element 714 thatexceeds that nominal current consumption amount by at least a thresholdamount corresponds to a logical high voltage. The threshold amount canbe chosen such that variations across different instances of theinfusion device 602 attributable to component tolerances or othermanufacturing variances are unlikely to result in the current sensingarrangement 716 generating a logical high voltage output when theswitching element 752 is not activated.

The circuitry 620 also includes a communications control module 710having a serial data input (SERIAL DATA IN) that is coupled to theoutput of the current sensing arrangement 716 to receive or otherwiseidentify bits of serial data transmitted by the infusion device 602. Thecommunications control module 710 also includes another serial datainput/output interface configured to communicate with a wirelesscommunications module 720 (or wireless transceiver) of the interfacingdevice 606. For example, the communications control module 710 and thewireless transceiver 720 may each include a serial peripheral interface(SPI) for communicating via a SPI bus coupled between the modules 710,720. The wireless transceiver 720 is also connected to an antenna 721 tofacilitate wireless communications with the infusion device 602, asdescribed in greater detail below. In one embodiment, the wirelesscommunications module 720 is configured to support communications via aBluetooth low energy (BLE) communications protocol, standard, orspecification. The illustrated communications control module 710 alsoincludes transmit and receive I/O interfaces which are coupled tocorresponding receive and transmit I/O interfaces of a signal conversionmodule 718, which, in turn, converts single-ended signals from thecommunications control module 710 to differential data signals providedto the computing device 604 via the USB connector 608, and vice versa.For example, the communications control module 710 may include universalasynchronous receiver/transmitter (UART) interfaces coupled tocorresponding UART interfaces on the signal converter 718 which convertsbetween UART data signals and USB data signals. That said, in someembodiments, the signal converter 718 may be integrated into thecommunications control module 710.

Depending on the embodiment, the communications control module 710 maybe implemented or realized with a general purpose processor, amicroprocessor, a controller, a microcontroller, a state machine, acontent addressable memory, an application specific integrated circuit,a field programmable gate array, any suitable programmable logic device,discrete gate or transistor logic, discrete hardware components, or anycombination thereof, designed to perform the functions described herein.In this regard, the steps of a method or algorithm described inconnection with the embodiments disclosed herein may be embodieddirectly in hardware, in firmware, in a software module executed by thecommunications control module 710, or in any practical combinationthereof. For example, the communications control module 710 may includeor otherwise access a data storage element or memory, which may berealized using any sort of non-transitory computer-readable mediumcapable of storing programming instructions for execution by thecommunications control module 710. The computer-executable programminginstructions, when read and executed by the communications controlmodule 710, cause the communications control module 710 to implement,support, or otherwise perform the tasks, operations, functions, andprocesses described in greater detail below.

Still referring to FIGS. 6-7, the infusion device connection arrangement610 electrically connects the voltage output from the voltage converter712 downstream of the current-sensing resistive element 714 to a supplyvoltage input node of the infusion device 602 via the battery connector(e.g., battery connector 280) within the infusion device 602. In thisregard, the capping member 630 is connected to the physicalcommunications medium 607 to receive the negative reference (or ground)voltage for the circuitry 620 from terminal 704 and the supply voltagefor the infusion device 602 from the end of the current-sensingresistive element 714 opposite the voltage converter 712. The batteryemulator 730 is electrically connected to the capping member 630 toreceive the ground and supply voltages, and in turn, provides those tothe appropriate terminals (or nodes) of the battery connector within theinfusion device 602. In this manner, the infusion device connectionarrangement 610 merely provides an interface between the internalcircuitry of the infusion device 602 and the physical communicationsmedium 607. The supply voltage input to the infusion device 602 isprovided to a voltage conversion module 742, such as a DC-to-DC boostconverter, that converts the input supply voltage (e.g., 1.5 Volts) to adifferent supply reference voltage (e.g., 3.3 Volts) that powers variouselements 740, 744, 746 of the infusion device 602.

As illustrated in FIG. 7, the internal infusion device circuitryincludes a switched resistance arrangement having a resistive element750 electrically connected between the input supply voltage node and theground voltage node via a switching element 752 configured electricallyin series with the resistive element 750. In this regard, the switchedresistance arrangement 749 is effectively connected between the batteryterminals (e.g., connector 280) of the infusion device 602. Theswitching element 752 is operated to regulate current flow through theresistive element 750, which, in turn, influences the current that flowsthrough the current-sensing resistive element 714 via the connectionarrangement 610. A control module 740 of the infusion device 602(alternatively referred to herein as the pump control module) includes aserial data output interface (SERIAL DATA OUT) that is coupled to theswitching element 752 to control activation of the switching element752, and thereby transmit serial data bits to the communications controlmodule 710, as described in greater detail below. The pump controlmodule 740 also includes another serial data input/output interfaceconfigured to communicate with a wireless communications module 744 ofthe infusion device 602. For example, the pump control module 740 andthe wireless transceiver 744 may each include a serial peripheralinterface (SPI) for communicating via a SPI bus coupled between themodules 740, 744. The wireless transceiver 744 is also connected to anantenna 745 to facilitate wireless communications with the wirelesstransceiver 720 of the interfacing device 606, as described in greaterdetail below.

The pump control module 740 may also include one or more additional I/Ointerfaces coupled to various additional or auxiliary modules 746 (e.g.,a motor driver module 507, a user interface 530, a display 226, and/orthe like) of the infusion device 602 to control operation of thosemodules 746. As described in greater detail below, when transmittingdata to the computing device 604 via the interfacing device 606, thepump control module 740 signals, commands, instructs, or otherwiseoperates the auxiliary modules 746 in respective operating modes thatresult in substantially constant current consumption by the auxiliarymodules 746 during transmission, so that the only fluctuations in thecurrent flowing through the resistive element 714 is attributable tooperation of the switching element 752. In this regard, duringtransmission, the pump control module 740 may also operate some of itsown internal components so that the current consumed by the pump controlmodule 740 is also substantially constant during operation of theswitching element 752.

Again, depending on the embodiment, the pump control module 740 may beimplemented or realized with a general purpose processor, amicroprocessor, a controller, a microcontroller, a state machine, acontent addressable memory, an application specific integrated circuit,a field programmable gate array, any suitable programmable logic device,discrete gate or transistor logic, discrete hardware components, or anycombination thereof, designed to perform the functions described herein.In this regard, the steps of a method or algorithm described inconnection with the embodiments disclosed herein may be embodieddirectly in hardware, in firmware, in a software module executed by thepump control module 740, or in any practical combination thereof Forexample, the pump control module 740 may include or otherwise access adata storage element or memory, which may be realized using any sort ofnon-transitory computer-readable medium capable of storing programminginstructions for execution by the pump control module 740. Thecomputer-executable programming instructions, when read and executed bythe pump control module 740, cause the pump control module 740 toimplement, support, or otherwise perform the tasks, operations,functions, and processes described in greater detail below.

In exemplary embodiments, the pump control module 740 is coupled to adata storage element (or memory) 748 that stores or otherwise maintainsoperational data pertaining to operations of the infusion device 602along with settings data that controls or otherwise dictates operationsof the infusion device 602. The operational data may include, forexample, historical delivery or dosage information, historical bloodglucose and/or sensor glucose measurements, alarm history, trace data,event logs, and/or other information that may be utilized to analyze,diagnose and/or debug operation of the infusion device 602. The settingsdata may include, for example, user-configurable alarm thresholds orsettings, user-configurable delivery settings (e.g., total daily dose, abasal infusion rate, or the like), control parameters (e.g., closed-loopproportional-integral-derivative (PID) gain parameters), and the like.As described in greater detail below, in exemplary embodiments, some orall of the operational data may be downloaded to the computing device604 from the infusion device 602 via the physical communications medium607 for analysis on the computing device 604, and conversely, modifiedor updated settings data may be uploaded to the infusion device 602 fromthe computing device 604 via a wireless communications session.

It should be understood that FIG. 7 is a simplified representation ofthe interfacing device 606 and internal circuitry of the infusion device602 for purposes of explanation and ease of description, and FIG. 7 isnot intended to limit the application or scope of the subject matter inany way. Thus, although FIG. 7 depicts direct electrical connectionsbetween components, alternative embodiments may employ interveningcircuit elements and/or components while functioning in a substantiallysimilar manner.

FIG. 8 depicts an exemplary data transfer process 800 suitable fortransferring data between two devices, such as between infusion device602 and computing device 604. The various tasks performed in connectionwith the data transfer process 800 may be performed by hardware,firmware, software executed by processing circuitry, or any combinationthereof. For illustrative purposes, the following description refers toelements mentioned above in connection with FIGS. 1-7. In practice,portions of the data transfer process 800 may be performed by differentelements of data communications system 600, such as, for example, theinfusion device 602, the computing device 604, the interfacing device606, the communications control module 710, the current sensingarrangement 716, the signal converter 718, the wireless communicationsmodule 720, the pump control module 740, the wireless communicationsmodule 744, and/or the switching element 752. It should be appreciatedthat the data transfer process 800 may include any number of additionalor alternative tasks, the tasks need not be performed in the illustratedorder and/or the tasks may be performed concurrently, and/or the datatransfer process 800 may be incorporated into a more comprehensiveprocedure or process having additional functionality not described indetail herein. Moreover, one or more of the tasks shown and described inthe context of FIG. 8 could be omitted from a practical embodiment ofthe data transfer process 800 as long as the intended overallfunctionality remains intact.

Referring to FIG. 8 and with continued reference to FIGS. 6-7, theillustrated process 800 begins by detecting or otherwise identifyingestablishment of an electrical connection between devices via a physicalcommunications medium, and in response, establishing or otherwiseinitializing wireless communications between the devices (tasks 802,804). For example, the pump control module 740 may detect a connectionwith a computing device 604 via a physical communications medium 607 inresponse to receiving a supply voltage from the voltage converter 742indicative of both device connection arrangements 608, 610 beinginserted in the respective devices 602, 604 concurrently. In someembodiments, the voltage converter 712 may be configured to provide avoltage that deviates from the nominal battery supply voltage by anamount that indicates, to the pump control module 740, that somethingother than a battery is inserted into the infusion device 602. Forexample, when the nominal battery supply voltage is 1.5 Volts, thevoltage converter 712 may be configured to provide, at least initially,a 2.5 Volt output to the physical communications medium 607. The pumpcontrol module 740 may monitor or otherwise identify the difference fromthe nominal battery supply voltage at the connector 280, and therebydetect or otherwise identify the establishment of an electricalconnection with an external device. In such embodiments, thecommunications control module 710 may be coupled to the voltageconverter 712 and configured to command, signal, or otherwise operatethe voltage converter 712 to adjust the output voltage on the physicalcommunications medium 607 down to the nominal battery supply voltageafter establishment of a wireless communications session with theinfusion device 602.

In response to detecting an electrical connection to the interfacingdevice 606 via the physical communications medium 607, the pump controlmodule 740 may automatically signal, command, or otherwise operate thewireless communications module 744 to attempt to establish wirelesscommunications with the interfacing device 606. For example, the pumpcontrol module 740 may cause the wireless communications module 744 toperform a discovery process to identify other devices that are proximateto or otherwise in the vicinity of the infusion device 602. Similarly,when the connection arrangement 608 establishes an electrical connectionwith the computing device 604, the communications control module 710 mayautomatically signal, command, or otherwise operate the wirelesscommunications module 720 to discover or otherwise identify the infusiondevice 602. Upon the wireless communications modules 720, 744discovering one another, a pairing process may be performed by thewireless communications modules 720, 744 to obtain and maintain uniqueidentification information associated with the other wirelesscommunications module 720, 744 for establishing a peer-to-peer wirelesscommunications session 724 between the infusion device 602 and theinterfacing device 606. Thus, upon the device connection arrangements608, 610 being inserted in the respective devices 602, 604 concurrently,the interfacing device 606 and the infusion device 602 may automaticallyestablish wireless communications.

In one or more embodiments, the pump control module 740 implements oneor more security measures to prevent establishment of a wirelesscommunications session with untrusted devices. For example, in responseto discovering a wireless communications module 720 associated withanother device, the pump control module 740 may automatically operatethe switching element 752 to transmit or otherwise provide, via thephysical communications medium 607, data bits corresponding toauthentication information used for pairing with the wirelesscommunications module 744. For example, the authentication informationmay be a secret code or key, such as a number, identifier, or the likethat is uniquely associated with the infusion device 602 or a randomnumber dynamically generated by the pump control module 740 upon eachiteration of the process 800. In practice, some embodiments could employeven more robust authentication schemes as desired. In the absence ofthe pump control module 740 receiving the authentication informationfrom the discovered wireless communications module via the pump wirelesscommunications module 744 within a timeout period, the pump controlmodule 740 may automatically command, signal, instruct, or otherwiseoperate the wireless communications module 744 to deny any pairingattempts with the discovered wireless communications module. Thus, thepump control module 740 may only allow establishment of wirelesscommunications sessions with an interfacing device 606 that includes aphysical communications medium 607 coupled to the infusion device 602.

The illustrated process 800 continues by identifying or otherwisedetermining the data to be uploaded or otherwise transmitted from theinfusion device (task 806). In some embodiments, the pump control module740 may automatically identify or determine the data to be transmittedto the computing device 604. For example, based on settings for theinfusion device 602 (which could be user-configurable) stored in memory748 of the infusion device 602, the infusion device 602 mayautomatically transmit particular types of data (or certain data sets)from the memory 748 whenever the infusion device 602 is connected to acomputing device 604 via the interfacing device 606. In otherembodiments, a user may manipulate one or more user interfacesassociated with the infusion device 602 to select or otherwise identifywhich types of data or data sets that the user would like to upload tothe computing device 604. In yet other embodiments, a user maymanipulate one or more user interfaces associated with the computingdevice 604 to select or otherwise identify which types of data or datasets that the user would like to download to the computing device 604from the infusion device 602. In such embodiments, upon selection of thedata to be transmitted, the computing device 604 may transmit orotherwise provide an indication of the selected data to thecommunications control module 710 (via the signal converter 718), which,in turn, commands or otherwise operates the wireless communicationsmodule 720 to transmit the indication of the selected data to the pumpcontrol module 740 via the wireless communications session 724.

After the data to be transmitted is identified, the data transferprocess 800 continues by operating components of the infusion device toconsume a substantially constant current while concurrently modulatingthe input current to the infusion device in a manner corresponding tothe data identified for transmission (tasks 808, 810). For example, thecontrol module 740 may command, instruct, or otherwise operate othermodules 746 of the infusion device 602 so that their current consumptionor demands do not fluctuate while concurrently activating anddeactivating the switching element 752 to modulate the current flow tothe infusion device 602 in a manner that corresponds to the bits of thedata being transmitted. For example, to transmit a logical high bit (orlogic ‘1’), the pump control module 740 may close, turn on, or otherwiseactivate the switching element 752 to draw current through the resistiveelement 750, which, in turn, increases current through the resistiveelement 714 and causes the current sensing arrangement 716 to generate alogical high bit (or logic ‘1’) at a serial data input to thecommunications control module 710. Conversely, to transmit a logical lowbit (or logic ‘0’), the pump control module 740 may open, turn off, orotherwise deactivate the switching element 752 to prevent currentthrough the resistive element 750, which, in turn, decreases currentthrough the resistive element 714 and causes the current sensingarrangement 716 to generate a logical low bit (or logic ‘0’) at theserial data input to the communications control module 710. In additionto transmitting bits of data, the pump control module 740 may alsotransmit bits according to various encryption and/or encoding schemesthat may be implemented to improve security, reliability, and the like.For example, the pump control module 740 may employ error correctingcodes while also encrypting or encapsulating data from the memory 748before transmission via the physical communications medium 607.

In exemplary embodiments, the data transfer process 800 verifies orotherwise confirms the transmitted data was received via the physicalcommunications medium and retransmitting any data that was not validlyreceived from the infusion device (tasks 812, 814). In one or moreexemplary embodiments, the communications control module 710 receivesthe serialized data transmission from the pump control module 740 viathe current sensing arrangement 716 and performs the error detection,decrypting and/or decoding corresponding to the encoding and/orencryption performed by the pump control module 740 to obtain the rawdata intended to be transmitted from the infusion device 602. In thisregard, when the communications control module 710 identifies orotherwise determines the data was successfully received and decodedand/or decrypted, the communications control module 710 mayautomatically transmit or otherwise provide an acknowledgment message tothe control module 740 using the wireless communications session 724established via the wireless communications module 720. Conversely, whenthe communications control module 710 detects or otherwise identifies anerror or other failure to accurately receive, decode, or decrypt the rawdata, the communications control module 710 may fail to provide anacknowledgment message. In the absence of receiving an acknowledgmentmessage via the wireless communications module 744 within a prescribedtimeout period, the pump control module 740 may automatically operatethe switching element 752 to resend the unacknowledged data to theinterfacing device 606. It should be noted that while the subject matteris described here in the context of the communications control module710 performing error detection, decryption and/or decoding andinitiating the transmission of acknowledgment messages back to theinfusion device 602, in alternative embodiments, the computing device604 may perform error detection, decryption and/or decoding and instructthe communications control module 710 when to send acknowledgmentmessages.

In exemplary embodiments, the data transfer process 800 continuesoperating components of the infusion device to consume substantiallyconstant current while concurrently modulating the input current to theinfusion device and monitoring for corresponding acknowledgment messagesuntil identifying or otherwise determining that the entirety of theselected data has been transmitted and received by the computing device(tasks 808, 810, 812, 814, 816). The illustrated process 800 alsoidentifies or otherwise determines whether the infusion device hasreceived data uploaded from the computing device, and in response,updates or otherwise modifies the stored data onboard the infusiondevice corresponding to the received data (tasks 818, 820). In anexemplary embodiment, after a user of the computing device 604 downloadsand reviews operational data from the infusion device 602 (e.g.,historical delivery and/or dosage data, alarm history, historical bloodglucose measurement data, trace data, and/or the like), the user maymanipulate a user interface associated with the computing device 604 tomodify aspects of pump operation. For example, the computing device 604may present a graphical user interface (GUI) that includes graphicalrepresentations of the data downloaded from the infusion device 602along with GUI elements that allow a user to modify alarm thresholds orsettings, delivery settings or control parameters (e.g., total dailydose amounts, closed-loop gain parameters, basal infusion rates, and thelike), or other aspects of the infusion device operation and then uploaddata corresponding to the modification to the infusion device 602 viathe interfacing device 606. In this regard, the signal converter 718converts the differential data signals received from the computingdevice into single-ended data signals provided to the communicationscontrol module 710, which, in turn, provides a corresponding serializeddata stream (with whatever encoding, encryption and/or error correctingcodes being utilized) to the wireless communications module 720 fortransmission to the infusion device 602 via the wireless communicationssession 724. Thereafter, in response to receiving indication of modifiedsettings data, the control module 740 may overwrite the correspondingdata in the memory 748 by storing or otherwise maintaining the receiveddata from the computing device 604 in lieu of the preceding settingsdata.

It should be appreciated that the wireless communications session 724between the devices 602, 606 may be persistently maintained while thedevices 602, 604 are concurrently connected via the interfacing device606 and/or physical communications medium 607 to transmit any desiredamount of data between the devices 602, 604. However, upon one of theconnection arrangements 608, 610 being decoupled from its respectivedevice 602, 604, power to at least one of the wireless communicationsmodules 720, 744 will be removed, thereby terminating the wirelesscommunications session 724. That said, the physical communicationsmedium 607 allows for relatively larger amounts of data to be securelytransmitted from the infusion device 602 to the computing device 604with a consistent and reliable throughput, and potentially in a shorterduration of time than could be achieved via the wireless communicationssession 724. Additionally, receipt acknowledgments from thecommunications control module 710 may be provided to the control module740 independent of the physical communications medium 607 (e.g., via awireless communications medium), thereby allowing the data to becommunicated with improved reliability without compromising thebandwidth of the physical communications medium 607. Thus, theinterfacing device 606 provides a convenient means for users toperiodically (e.g., weekly, biweekly, monthly, or the like) download abulk of pump operational data to a computing device 604 for morecomprehensive review and/or analysis in a manner that is relativelyquick, secure, and reliable.

For the sake of brevity, conventional techniques related to wirelesscommunications, serial bus communications, pairing, data encoding, datatransmission, modulation, current sensing, glucose sensing and/ormonitoring, closed-loop glucose control, and other functional aspects ofthe subject matter may not be described in detail herein. In addition,certain terminology may also be used in the herein for the purpose ofreference only, and thus is not intended to be limiting. For example,terms such as “first”, “second”, and other such numerical termsreferring to structures do not imply a sequence or order unless clearlyindicated by the context. The foregoing description may also refer toelements or nodes or features being “connected” or “coupled” together.As used herein, unless expressly stated otherwise, “coupled” means thatone element/node/feature is directly or indirectly joined to (ordirectly or indirectly communicates with) another element/node/feature,and not necessarily mechanically.

While at least one exemplary embodiment has been presented in theforegoing detailed description, it should be appreciated that a vastnumber of variations exist. It should also be appreciated that theexemplary embodiment or embodiments described herein are not intended tolimit the scope, applicability, or configuration of the claimed subjectmatter in any way. For example, the subject matter described herein isnot necessarily limited to the infusion devices and related systemsdescribed herein. Moreover, the foregoing detailed description willprovide those skilled in the art with a convenient road map forimplementing the described embodiment or embodiments. It should beunderstood that various changes can be made in the function andarrangement of elements without departing from the scope defined by theclaims, which includes known equivalents and foreseeable equivalents atthe time of filing this patent application. Accordingly, details of theexemplary embodiments or other limitations described above should not beread into the claims absent a clear intention to the contrary.

What is claimed is:
 1. A method of operating a medical device, themethod comprising: detecting, by the medical device, an interfacingdevice coupled to the medical device; initializing a wirelesscommunications session with the interfacing device in response todetecting the interfacing device; modulating, by the medical device, anelectrical signal between the interfacing device and the medical deviceto transmit data from the medical device to the interfacing device; andreceiving, by the medical device via the wireless communicationssession, communications from the interfacing device.
 2. The method ofclaim 1, wherein receiving communications comprises the medical devicereceiving an acknowledgment of receipt of the data from the interfacingdevice via the wireless communications session.
 3. The method of claim1, wherein detecting the interfacing device comprises detectinginsertion of a connection arrangement of the interfacing device into themedical device.
 4. The method of claim 3, wherein modulating theelectrical signal comprises modulating a current flowing from theinterfacing device to the medical device via the connection arrangement.5. The method of claim 1, wherein modulating the electrical signalcomprises modulating a current flowing from the interfacing device tothe medical device via a physical communications medium and a connectionarrangement coupled to the medical device, wherein the interfacingdevice includes a current sensing arrangement electrically in serieswith the connection arrangement.
 6. The method of claim 5, the medicaldevice including a switched resistance arrangement coupled betweenterminals of the medical device, the terminals being coupled to theconnection arrangement, wherein modulating the current comprisesactivating the switched resistance arrangement in a manner correspondingto the data.
 7. The method of claim 1, the communications comprisingsettings data, the method further comprising storing, by the medicaldevice, the settings data received via the wireless communicationssession, wherein the settings data influences subsequent operation ofthe medical device.
 8. The method of claim 1, further comprisingreceiving, by the medical device via the wireless communicationssession, an indication of the data to be transmitted prior to modulatingthe electrical signal.
 9. The method of claim 1, further comprisingoperating one or more components of the medical device to maintainsubstantially constant current consumption while modulating theelectrical signal.
 10. The method of claim 1, wherein initializing thewireless communications session comprises: modulating, by the medicaldevice, the electrical signal to transmit authentication information tothe interfacing device via a physical communications medium; andestablishing the wireless communications session in response to themedical device wirelessly receiving the authentication information fromthe interfacing device.
 11. A system comprising: an interfacing devicecomprising: a connection arrangement for a physical communicationsmedium; and a first wireless communications module; and a medical devicecomprising: a data storage element to maintain operational data; aswitched resistance arrangement coupled to a terminal of the medicaldevice; a second wireless communications module; and a control modulecoupled to the switched resistance arrangement and the second wirelesscommunications module to initiate a wireless communications sessionbetween the first and second wireless communications modules in responseto detecting the connection arrangement coupled to the terminal, operatethe switched resistance arrangement to modulate an electrical signal onthe physical communications medium in a manner corresponding to theoperational data, and receive acknowledgment of the operational datafrom the interfacing device via the wireless communications session. 12.The system of claim 11, wherein the interfacing device further comprisesa sensing arrangement electrically in series with the physicalcommunications medium and the connection arrangement to produce anoutput influenced by the electrical signal.
 13. The system of claim 12,wherein the interfacing device further comprises a second control modulecoupled to the first wireless communications module and the output ofthe sensing arrangement to receive the operational data based on theoutput of the sensing arrangement and transmit the acknowledgment inresponse to receiving the operational data.
 14. The system of claim 12,wherein: the connection arrangement conforms to a battery receptaclewithin a housing of the medical device; and the terminal comprises abattery connector.
 15. The system of claim 11, wherein the interfacingdevice further comprises: a second connection arrangement for thephysical communications medium; and a converter module coupled betweenthe second connection arrangement and the connection arrangement toconvert an input voltage to the second connection arrangement to abattery supply voltage for the medical device.
 16. The system of claim15, wherein the interfacing device further comprises: a sensingarrangement electrically in series with the physical communicationsmedium between the converter module and the connection arrangement, thesensing arrangement producing an output influenced by the electricalsignal; and a second control module coupled to the first wirelesscommunications module and the output of the sensing arrangement toreceive the operational data based on the output of the sensingarrangement and transmit the acknowledgment in response to receiving theoperational data.
 17. A medical device comprising: a supply voltageterminal; a data storage element; a switched resistance arrangementcoupled to the supply voltage terminal; a wireless communicationsmodule; and a control module coupled to the switched resistancearrangement and the wireless communications module to transmitoperational data maintained in the data storage element by operating theswitched resistance arrangement to modulate an input current at thesupply voltage terminal in a manner corresponding to the operationaldata and receive acknowledgment of the transmitted operational data viathe wireless communications module.
 18. The medical device of claim 17,wherein the control module initiates a wireless communications sessionvia the wireless communications module prior to transmitting theoperational data.
 19. The medical device of claim 18, wherein thecontrol module receives indication of the operational data to betransmitted via the wireless communications session prior totransmitting the operational data.
 20. The medical device of claim 17,further comprising a motor operable to deliver fluid to a body of auser, the fluid influencing a physiological condition of the user,wherein the operational data comprises historical delivery datacorresponding to operation of the motor.